Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

ABSTRACT:

Background

Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting.

Methods

The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report pe

SUBMITTER: Boutzoukas AE 

PROVIDER: S-EPMC9918704 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature